Hydrophilic Acrylic Intraocular Lens

Sponsor

EyeKon Medical, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00708331

Collaborator

(none)

Enrollment

Locations

Arm

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Hydrophilic Acrylic Intraocular Lens after cataract surgery

Condition or Disease	Intervention/Treatment	Phase
Cataract Extraction	Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

SC25-FOLD Hydrophilic Acrylic Intraocular Lens

Study Start Date :

Aug 1, 2002

Actual Primary Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens 2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.

Arm

Intervention/Treatment

Experimental: 1

Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens

2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.

Outcome Measures

Primary Outcome Measures

Visual Acuity [At all pre/post op CRFs for 2 yrs]

Secondary Outcome Measures

Adverse Events [2yrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye
The patient is willing and able to complete all required postoperative visits.
The patient is willing to sign a statement of informed consent.

Preoperative Exclusion Criteria:

The patient is under the age of 18
The patient has had prior intraocular surgery in the operative eye.
The patient has systemic diseases with ocular manifestations (e.g. diabetes, complications of immune deficiency syndrome), which may contribute to postoperative confounding of data interpretation.
The patient's worst seeing eye is 20/70 or worse.
The patient has multiple surgical procedures at the time of implant.
The patient has chronic use of steroids, immunosuppressive and/or antineoplastic agents.
The patient has acute infection, inflammation of the eye.
Iris atrophy
Proliferative diabetic retinopathy.
Chronic, medically uncontrolled glaucoma
Chronic uveitis, iritis, iridocyclitis or rubeosis of the lids
Rubella, traumatic or congenital/developmental cataract.
Severe retinal pathology (e.g. retinal tear, detachment, etc).

Operative Patient Exclusion Criteria

Capsular rupture
Vitreous loss
Hyphema
Zonular disinsertion
Surgical Complications- In the event of a complication during surgery, the surgeon should decide whether the stability of the hydrophilic acrylic lens would be compromised by the complication, e.g. in the event of zonular damage of major capsule rupture. If the lens stability would be compromised, the hydrophilic acrylic lens should not be implanted and the surgeon should make arrangements to implant an alternative lens.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cape Coral Eye Center	Cape Coral	Florida	United States	33904
2	Cataract and Refractive Institute of Florida	Cape Coral	Florida	United States	33990
3	Eye Centers of Florida	Fort Myers	Florida	United States	33901
4	Riverside Park Surgicenter	Jacksonville	Florida	United States	32204
5	The Eye Institute of West Florida	Largo	Florida	United States	33770
6	The Perich Eye Center	New Port Richey	Florida	United States	34655
7	Central Florida Eye Institute	Ocala	Florida	United States	34474
8	St. Lukes Cataract and Laser Center	Tarpon Springs	Florida	United States	34688
9	Comprehensive Eye Care Ltd.	Washington	Missouri	United States	63090

Sponsors and Collaborators

EyeKon Medical, Inc.

Investigators

Study Director: James Garvey, M.D.,
Principal Investigator: David C Brown, M.D., Eye Centers of Florida
Principal Investigator: Michael S Korenfeld, M.D., Comprehensive Eye Care LTD
Principal Investigator: James E Croley, M.D., Cataract and Refractive Institute of Florida
Principal Investigator: Larry Perich, D.O., The Perch Eye Center
Principal Investigator: Thomas L Croley, M.D., Central Florida Eye Institute
Principal Investigator: Farrell C Tyson, M.D, Cape Coral Eye Center
Principal Investigator: James P Gills, M.D., St. Lukes Cataract and Laser Center
Principal Investigator: Robert Weinstock, M.D, The Eye Institute of West Florida